(29 days)
Contour SE™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.
The Contour SE TM Microspheres are spherical embolic particles and are available in a variety of particle sizes and are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. These particles are provided in a sterilized glass vial.
The provided documents are a 510(k) summary and an FDA clearance letter for Contour SETM Microspheres. These documents do not contain detailed acceptance criteria or a study that specifically "proves" the device meets acceptance criteria in the way a clinical trial report or a comprehensive validation study would for a new AI or diagnostic device.
Instead, this submission is for a medical device seeking substantial equivalence to existing predicate devices. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the new device is as safe and effective as legally marketed predicate devices, not on achieving specific performance metrics in a clinical context.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not present a formal table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) like one would expect for an AI diagnostic tool. Instead, the "acceptance criteria" implicitly revolve around demonstrating biocompatibility and substantial equivalence to predicate devices. The "reported device performance" is essentially the finding of biocompatibility and substantial equivalence.
| Aspect of Acceptance Criteria | Reported Device Performance (from the document) |
|---|---|
| Biocompatibility | "The Contour SETM Microspheres have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use." |
| Substantial Equivalence | "The Contour SETM Microspheres have been tested and compared to the Summary of predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." |
| Intended Use | Indicated for "embolization of hypervascular tumors and arteriovenous malformations" (matches predicate devices). |
| Safety and Efficacy | Implicitly demonstrated through substantial equivalence to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in these documents. The testing for biocompatibility per ISO 10993 would involve specific sample sizes and protocols as defined by that standard, but the exact numbers are not detailed here. Similarly, the comparison to predicate devices would involve testing of the Contour SE™ Microspheres, but the "sample size" of devices tested is not provided.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. Biocompatibility testing is typically performed in laboratory settings. Given the nature of a 510(k) for a physical medical device, the "data" would primarily come from laboratory testing of the physical properties and biological interactions of the microspheres, and possibly from existing literature or data on the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this 510(k) submission for a physical embolic device. "Ground truth" established by experts (like radiologists for image analysis) is relevant for diagnostic or AI devices, not for assessing the basic safety and performance of microspheres in a substantial equivalence pathway. The "ground truth" here is the scientific standards of biocompatibility (ISO 10993) and the established safety and efficacy of the predicate devices.
4. Adjudication Method for the Test Set
This is not applicable as it pertains to expert consensus on interpretation, which is not the primary assessment method for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
No, a MRMC comparative effectiveness study was not done, and it would not be relevant for this type of device submission. MRMC studies are used for evaluating diagnostic performance, particularly of AI-assisted systems, comparing human reader performance with and without AI. This submission is for a physical embolic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm or AI device. Therefore, a standalone performance assessment in the context of computing algorithms is not applicable.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" is adherence to the ISO 10993 series of standards, which are internationally recognized guidelines for evaluating the biological compatibility of medical devices. For substantial equivalence, the "ground truth" is established by comparing the device's characteristics (materials, design, performance, intended use) to those of legally marketed predicate devices that have already demonstrated safety and efficacy.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. This is not an AI/ML device.
In summary:
The provided documents describe a 510(k) submission for a physical medical device (Contour SETM Microspheres) seeking clearance based on substantial equivalence to predicate devices. The "acceptance criteria" and "study" are framed around demonstrating biocompatibility according to ISO standards and showing that the device is as safe and effective as existing, legally marketed embolization devices. This is a different paradigm than what would be described for an AI-powered diagnostic tool, which typically involves detailed performance metrics, test sets, expert ground truth, and comparative effectiveness studies.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).